Tobacco Documents Online

t- • IEHR WHAT IS IEHR? Institute for Evaluating Health Risks the offices of: Cooley Godward Castro Huddleson & Tatum One Maritime Plaza, twenty first floor San Francisco, California 94111 (415) 981-5252 The Institute for Evaluating Health Risk is a 501c3 non-profit corporation organized in California to "provide an independent mechanism to improve the evaluation of health risks, among which are those associated with substances addressed by the Safe Drinking Water Act of 1986 of the State of California" (from the Articles of Incorporation). THE PUBLIC POLICY BACKGROUND .6 In 1986, the citizens of the State of California voted by a substantial majority in favor of "Proposition 65", the Safe Drinking Water and Toxics Enforcements Act of 1986_ (referred to in this statement as "Proposition 65"). The new state law substantially alters the traditional process for regulating both testing for, and enforcement of, public safety relating to chemicals known to cause cancer or adverse reproductive effects. At the same time, Proposition 65 brings into focus the need for much more rapid determination of the extent of adverse effects of toxic materials. At the present time, Proposition 65 is the law only in California; however, it is quite likely that other regulatory changes which require a similar need for risk assessment will occur in other states and under federal law. Proposition 65 prohibits materials known to cause adverse effects to be (i) released by certain businesses without a warning to those who will be exposed, or (ii) discharged into sources of drinking water except when there is a finding that the amount of such a release or discharge will not create a significant risk to public health. To date, nearly 300 chemicals and substances have been listed by the state as being "known" to cause cancer or adverse reproductive effects at some level of human exposure. The list includes chemicals which are used in the activities of most Californians and are regularly contained in or are the by-products of manufacturing in the normal course of commercial activity in California and elsewhere. As noted, the law does not prohibit release without warning or discharge to drinking water where it can be determined that the amount of the release does not create a significant risk to humans. Assessing whether there is a significant risk to public health involves two elements: (1) what amount is needed to cause adverse health effects

i IEHR - 13arrative p . 2 (the toxic potency of the chemical) and; (2) what amount of those substances are present at the point at which the law determines that measurement must occur to prevent citizens from being exposed by a release. Testing to determine public safety in these two respects is exceedingly complex - particularly in respect of chemicals or substances where little is known beyond the fact that risk of human health effects exists when persons are exposed to such chemicals at relatively high levels. Proposition 65 places the burden of proving "no significant risk" on the businesses which release or discharge toxic chemicals or substances. The State government has developed regulations which specify the level of risk it judges to be significant, and with respect to some (but not all) of the identified toxic chemicals, the regulations determine the "safe levels" (that is, the threshold amount of a particular chemical below which, given the potency of the particular chemical, there would be an insignificant risk of adverse effects). However, the weakness in the data base - and problems in interpreting that data base - for determining "safe levels", the absence of any determination of a safe level for many toxic chemicals, and the difficulty (even assuming a well- established safe level for a particular chemical) of assessing the actual level of exposure resulting from a particular release or discharge all combine to make scientifically-based determinations of "no significant risk" for the many chemicals listed extremely difficult. Proposition 65 provides support for litigants - in both the public and private bars - who wish to challenge particular companies' "no significant risk" assessments. In effect, Proposition 65 provides a new regulatory program that is to be implemented through the dynamic of businesses' determining "no'significant risk" levels and litigants contesting those determinations. THE INSTITUTE The Institute for Evaluating Health Risk is a new institution, created and organized under the laws governing non-profit corporations in the State of California solely to test for public safety in the unusual context created for such testing by the new California law. It has been recognized as a non-profit, charitable institution by the federal Internal Revenue Service and the Tax Franchise Board in California. The Institute seeks to support the implementation of Proposition 65 in an effective, coherent way by establishing a credible information base and risk assessment methodology, based on excellent science, that would be available to all parties with a concern for the quality of risk assessments used in compliance with this law.

-LEKR - Karrative p. 3 The need for credible information and competent technical judgment is widely recognized among all knowledgeable segments of the California citizenry. It is recognized by the environmental lawyers who wrote the legislation, by the top state public officials who are attempting to administer the law, by the businesses whose operations generate such potential releases, and by members of the technical community whose work contributes to the data base - and the criteria for its interpretation - from which such technical judgments are derived. There is also a growing recognition in the general populace, as indicated by recent stories in California media, that such a source of credible judgments is needed if they are to be protected effectively by the new law. At present, there is no organization in California - or anywhere in the nation - which can provide any such source of technical judgment except by providing fragmentary information in a form often not useful for the complete judgment-making process required by California's new law. The Institute for Evaluating Health Risks has been created, first, to determine whether any mechanism to fill this very major gap can be developed in a way that will provide the credible help that is needed. To secure both the competent human resources and information retrieval necessary, the organization must be viewed as independent and must secure adequate funding. It must forge technically acceptable methods for making these very complex judgments more rigorous. It must be organized and governed with careful attention to becoming recognized as rendering its judgments - to government, industry and the public - in ways that are objective, highly competent and understandable to the public which needs this information. If it proves feasible for an organization to make this contribution to environmental safety, the organization will develop into a resource which will be viewed as extremely important not only to California but to the nation as a whole. GOVERNANCE AND ORGANIZATION Careful attention has been given in the formation of the Institute to assure that its feasibility study and later development is conducted in a way that is attentive to all of the concerns described. During the period when the possibility of incorporating the Institute was being considered, advice and expressions of support for the initiative were obtained from representatives of all affected interests. Great care was taken to put the governance of the institution under the direction of leaders in the California community who are recognized for their technical competence, leadership and integrity. The Board of Directors who agreed to undertake governance of this venture and were gathered to approve the actual formation of

IEKR - Karrative p. 4 the Institute meet these three tests to an unusual degree. The Board is composed of seven persons, six of whom are nationally known for superior technical competence in the required disciplines. All seven Board members have gained national recognition for leadership ability and each has run a major institution. Each is perceived to be a person of unusual integrity as well as competence in making technical judgments. And there are members of the Board known to all affected communities in the State to be particularly knowledgeable about and committed to the public interest. These seven persons are: Richard K. Atkinson, Chancellor of the University of California at San Diego, President of the American Association for the Advancement of Science and formerly the Director of the National Science Foundation; William F. Ballhaus (Chairman of the Board), recent past President of Beckman Instruments, member of the Advisory Councils of the National Academy of Sciences and the NationalrtAcademy of Engineers and nationally recognized as a pioneer in developments for aeronautical and biological sciences; Theodore L. Hullar, Chancellor of the University of California, Davis, a medicinal chemist, former Deputy Commissioner for the Department of Environmental Conservation in the State of New York, and Chairman of the Board on Agriculture of the National Research Council; Donald Kennedy, President of Stanford University and a former Commissioner of the Food and Drug Administration and a former member of the staff of the federal Office of Science and Technology Policy; Melvin Lane, Chairman and Publisher, Sunset Publications, Chairman of the Board of the California Environmental Trust, and former Chairman of the Board of the Conservation Foundation and of the California Coastal Commission; David Packard, Chairman of Hewlett- Packard and Co., a member of the White House Science Council, former Vice Chairman of the California Nature Conservancy ana an internationally-known leader in the advancement of computer and information technology; and Rosemary Schraer, Chancellor, University of California at Riverside, former Associate Provost, Pennsylvania State University, a fellow of the American Association for the Advancement of Science and a nationally recognized biochemist and professor of biochemistry. The Board has made considerable progress in identifying key leadership, locating the Institute, and obtaining expert input into the scope and structure of the Institute: Leadership: To implement the initial start-up and review of the Institute's feasibility, the Board named Charles W. Powers as Acting Executive Director, Chief Executive Officer and Chief Financial Officer. Powers is President of the Institute for Responsible Management, and is a nationally-known manager of initiatives of this type who conceived and then served as the founding CEO of the

, 1EHR - 13arrative p. 5 Health Effects Institute (Cambridge, Massachusetts) and Clean Sites, Incorporated (Alexandria, Virginia). Michael Traynor, a partner in Cooley Godward Huddleson and Tatum, has been named Acting Secretary of the Corporation. The Board of Directors has recently reached an agreement with John A. Moore to become the permanent chief executive officer. Dr. Moore, who will assume his responsibilities in September, brings a distinguished record as both a scientist and a regulator who has unequaled experience in wrestling with the risk assessment issues which are at the heart of IEHR's mission. He served in academic posts at Western Reserve and Michigan State Universities before holding a variety of senior posts at the National Institute for Environmental Health Sciences (NIEHS) between 1969-83. He was Deputy Director of the National Toxicology Program at NIEHS, before joining The Environmenta; Protection Agency as Assistant Administrator, Office of Pesticides and Toxic Substances in 1983. During his final year before leaving the Agency in July 1989, Dr. Moore was Acting Duputy Administrator - and for a short time Acting Administrator - of the Agency. Location: The Institute is currently completing negotiations with the National Academies of Science and Engineering to establish IEHR's headquarters in the NAS-NAE Beckman Center at Irvine California later in the summer of 1989. Until that time, IEHR's official headquarters are in the offices of its legal counsel, Cooley, Godward, Castro, Huddleson and Tatum at One Maritime Plaza in San Francisco. Structure: The Board has given considerable attention to how it should limit the scope of its work and structure the Institute internally to carry-out those tasks. It assumed that the Institute will rely heavily on premier scientific talent, from wherever it may be found, to be formed into Committees and to provide the primary guidance to the Institute's scientific work. The staff will similarly be of high quality and be of a size to appropriately support the work of the scientific committees. Although final decisions as to specific tasks, chronology of activity, structure and organization of the needed human resources will await completion of the review, the following approach to scope and structure is now being considered by the Board of Directors: A. Creation of two expert panels of nationally-known scientists who would oversee the work of the Institute in two areas: 1) the conduct of risk assessments and generic exposure models to meet the tests of Proposition 65; and 2) the review for the purposes of quality assurance of available literature needed to develop risk assessments and exposure scenarios. Since March of 1989, Acting Executive Director Powers has, at the Board's direction, sought and

. ~EAR - Narrative p . 6 obtained advice on how IEHR should be organized and what its priorities should be from many of the nation's leading environmental scientists. Many of those scientists have expressed willingness to serve on the IEHR scientific committees if requested to do so by the Board. B. Creation of a staff of nationally-prominent persons skilled in risk assessment techniques and comprehension of the needed scientific and technical disciplines whose expertise is required in their development. C. Development of a funding base that combines unrestricted grants and funds to the Institute and also includes contracts with governmental, industrial and possibly other entities for work on specific chemicals and exposure scenarios. It is anticipated that while much of the work of the Institute wiI'1n be done "in house", the Institute will contract for outside services in the scientific and technical consultant community and in the academic community for some of its risk assessment development work. It will encourage the development of effective risk assessment efforts in all sectors. Because of the stature of its Board, which will provide an "umbrella" of recognized competence and integrity, it is anticipated that both start-up and sustaining revenue for the Institute can be obtained. General commitments of support from elements of the foundation and industrial community were made in discussions held prior to formation of the Institute with senior leadership of the industrial and foundation communities. Industrial commitments have come from companies in the banking, construction, pharmaceutical, oil, paper, real estate development, retail, and electric utility industries. Officials of the California Department of Health Services and relevant federal agencies express enthusiasm for being able to contract with the Institute to conduct needed risk assessments. July, 1989